Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
Study NCT ID:
NCT04202666
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2019-11-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2019-11-28', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'peristomy skin complication rate', 'timeFrame': 'one month', 'description': 'peristomy skin complication rate'}], 'secondaryOutcomes': [{'measure': '(2) life quality stomy care questionnaire', 'timeFrame': 'one month', 'description': 'life quality stomy care questionnaire'}, {'measure': '(3) stomy appliance satisfaction questionnaire', 'timeFrame': 'one month', 'description': 'stomy appliance satisfaction questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peristomy skin complication', 'convex skin barrier'], 'conditions': ['Stoma Colostomy', 'Stoma Ileostomy']}, 'referencesModule': {'references': [{'pmid': '17228209', 'type': 'BACKGROUND', 'citation': 'Colwell JC, Beitz J. Survey of wound, ostomy and continence (WOC) nurse clinicians on stomal and peristomal complications: a content validation study. J Wound Ostomy Continence Nurs. 2007 Jan-Feb;34(1):57-69. doi: 10.1097/00152192-200701000-00010.'}, {'pmid': '17893429', 'type': 'BACKGROUND', 'citation': 'Bosio G, Pisani F, Lucibello L, Fonti A, Scrocca A, Morandell C, Anselmi L, Antonini M, Militello G, Mastronicola D, Gasperini S. A proposal for classifying peristomal skin disorders: results of a multicenter observational study. Ostomy Wound Manage. 2007 Sep;53(9):38-43.'}, {'pmid': '21030726', 'type': 'BACKGROUND', 'citation': 'Beitz J, Gerlach M, Ginsburg P, Ho M, McCann E, Schafer V, Scott V, Stallings B, Turnbull G. Content validation of a standardized algorithm for ostomy care. Ostomy Wound Manage. 2010 Oct;56(10):22-38.'}, {'pmid': '22679479', 'type': 'BACKGROUND', 'citation': 'Meisner S, Lehur PA, Moran B, Martins L, Jemec GB. Peristomal skin complications are common, expensive, and difficult to manage: a population based cost modeling study. PLoS One. 2012;7(5):e37813. doi: 10.1371/journal.pone.0037813. Epub 2012 May 24.'}, {'pmid': '28834934', 'type': 'BACKGROUND', 'citation': 'Hoeflok J, Purnell P. Understanding the role of convex skin barriers in ostomy care. Nursing. 2017 Sep;47(9):51-56. doi: 10.1097/01.NURSE.0000516224.24273.88. No abstract available.'}, {'pmid': '28684936', 'type': 'BACKGROUND', 'citation': 'Steinhagen E, Colwell J, Cannon LM. Intestinal Stomas-Postoperative Stoma Care and Peristomal Skin Complications. Clin Colon Rectal Surg. 2017 Jul;30(3):184-192. doi: 10.1055/s-0037-1598159. Epub 2017 May 22.'}]}, 'descriptionModule': {'briefSummary': 'The incidence of peristomy skin complication ranges from 15% to 65%. It is a serious issue and problem for patients care.The type of skin barrier is associated with peristomy skin complication. How to choose suitable skin barrier is important.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>20\n* Receive colostomy or ileostomy\n* Agree to join the trial and sign the informed consent form\n\nExclusion Criteria:\n\n* Liver cirrhosis\n* Renal insufficiency\n* Severe malnutrition\n* Unstable vital sign\n* Not suitable after evaluation by Principal Investigator'}, 'identificationModule': {'nctId': 'NCT04202666', 'briefTitle': 'The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '201901217A3C601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'not convex skin barrier', 'description': 'no intervention'}, {'type': 'EXPERIMENTAL', 'label': 'convex skin barrier', 'description': 'intervention', 'interventionNames': ['Device: convex skin barrier']}], 'interventions': [{'name': 'convex skin barrier', 'type': 'DEVICE', 'description': 'Total 300 patients and grouping in 1:1 ratio.(1)peristomy skin complication (30 mins) (2)life quality stomy care (3-5 mins) (3)stomy appliance satisfaction (3-5 mins)', 'armGroupLabels': ['convex skin barrier']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wan Hsiang Hu', 'role': 'CONTACT', 'email': 'gary.hu0805@gmail.com', 'phone': '+886-7-7317123', 'phoneExt': '8008'}], 'facility': 'Chang Gung Memorial Hospital,Kaohsiung', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Wan Hsiang Hu', 'role': 'CONTACT', 'email': 'gary.hu0805@gmail.com', 'phone': '886-975056227'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'ConvaTect, Taiwan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'Wan-Hsiang Hu', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}